CompletedNot Applicable

Hydroxychloroquine for Thrombosis Prevention and Antiphospholipid Antibody Reduction in Primary Antiphospholipid Syndrome

Greece50 participantsStarted 2013-01-15

Plain-language summary

This is an interventional drug study designed as a pilot for a randomized clinical trial, aimed at assessing the effect of hydroxychloroquine on the incidence rate of thrombosis in patients with primary antiphospholipid syndrome as the main outcome, as well as the safety of hydroxychloroquine administration in this population. In addition, the effect of hydroxychloroquine on antiphospholipid antibody titers will be assessed.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. ≥4 American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE)
✕. ACR classification criteria for other systemic autoimmune disorders
✕. active malignancy
✕. treatment with Hydroxychloroquine (HCQ) in the previous 12 months
✕. history of serious adverse events or contraindication to HCQ including a history of HCQ allergy, HCQ eye toxicity, or glucose-6-phosphate dehydrogenase deficiency, uncontrolled seizure disorder, liver enzyme elevation \>2-fold the upper normal limit, and creatinine clearance \<30ml/min

What they're measuring

Incident acute thrombosis in the venous or arterial circulation

Timeframe: 3 years

Trial details

NCT IDNCT04153201

SponsorNational and Kapodistrian University of Athens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-01

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